Certain vascular interventions involves the insertion of a procedural sheath through a puncture in an artery. An internal lumen of the procedural sheath provides a passageway for the insertion of an interventional device into the artery and to an area of treatment. In a typical procedure, the procedural sheath is inserted into the artery and an intervention is performed using the interventional device, which is inserted into the artery via the procedural sheath. At the end of the procedure, the procedural sheath is removed from the artery and exchanged with a vessel closure device delivery sheath, which provides a passageway for delivery of a vessel closure device to the opening in the artery.
It is important to achieve hemostasis during the exchange of the procedural sheath with the vessel closure device delivery sheath in order to avoid a loss of blood. Unfortunately, the exchange procedure provides an opportunity for loss of blood and also for damage to the blood vessel as the sheaths are exchanged.
In certain clinical procedures, for example procedures requiring access to the carotid arteries, the consequences of failure to achieve complete hemostasis or causing vessel injury during such an exchange procedure can be extreme. For such transcarotid procedures, if full hemostasis is not achieved, the resultant hematoma may lead to loss of airway passage and/or critical loss of blood to the brain, both of which lead to severe patient compromise and possibly death. Alternately, a vessel injury or dissection may require adjunct repair and lead to prolonged procedure time and risk of complication.